HIRA to revise guidelines on new drugs utility assessment

New job posting for research services…The guideline will be useful for assessing drugs on the cost-effectiveness evaluation waiver track

The Health Insurance Review and Assessment Service (HIRA) will revise the guidelines on indirect comparison for assessing the clinical utility of new drugs.

 

For this purpose, HIRA is currently recruiting researchers for contract research work.

 

On the 1st, the HIRA initiated public bidding for ‘Research services to revise guidelines on indirect comparison for assessing the clinical utility of new drugs.’ “When used as a resource for evaluating clinical utility of new drugs, direct comparison with substitute drugs through randomization are prioritized to assess their efficacy improvements.

 

However, in cases where the submitted product was the sole treatment group in a clinical study or where no direct comparison data with a substitute drug is available, an evaluation basis through a valid indirect comparison becomes necessary,” the HIRA explained.

 

“Based on the findings of the ‘Research on developing the guidelines on indirect comparison for assessing the clinical utility of new drugs (2010),’ the guidelines on the required documentation for new drugs will be formulated.

 

The guidelines will help applicants submit objective effect comparison data for new drugs, and they will also serve as a resource for assessing the suitability and cost-effectiveness of new drugs.

 

However, revisions to domestic guidelines may be necessary to accommodate improved methods, particularly when overseas countries have revised their guidelines,” the HIRA added.

 

Furthermore, once the system updates based on last year’s 'Research on the improvement of the cost-effectiveness evaluation waiver system for drugs (current status and evaluation)’ are implemented, the guideline will serve various uses.

 

According to findings from last year’s research on improving the cost-effectiveness evaluation waiver system for drugs, the existing waiver system will change into a ‘deferred’ system.

 

Drugs that are granted deferred status will have their clinical utility assessed during the post-reimbursement management evaluation.

 

The post-reimbursement evaluation is expected to be important for the drugs that are granted cost-effectiveness deferment.

 

“There are increasing cases of drugs that cannot produce direct comparison clinical data, such as in cases of anti-cancer drugs and orphan drug treatments featuring a single treatment group in clinical research.

 

Consequently, the indirect comparison method is expected to become a valuable source following the revision to the cost-effectiveness evaluation waiver system for drugs,” the HIRA explained.

 

The HIRA plans to sign a contract with external services in February and begin research in March.

 

The deadline for submitting the final report is set for December.